Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeCLas Tool
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
MECLAS (Metals Classification Tool, version V5.2) classification for Slimes and sludges, electrolytic tin refining
Author:
ARCHE Consulting
Year:
2018
Bibliographic source:
MECLAS webpage: www.meclas.eu
Report Date:
2018

Materials and methods

Principles of method if other than guideline:
Aquatic toxicity of the UVCB substance was determined by classifying based on Mixture rules from EU CLP ( tier 1= summation of classified components or Tier 2 = additivity of soluble components to derive Hazard class) and back calculation to the corresponding L(E)C50 range

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
<= 1 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
other: most sensitive species

Any other information on results incl. tables

According to MeClas, the substance is classified as acute 1 to environment.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Good quality estimate of the L/EC50 of the UVCB substance.
The substance is classified as acute cat 1 to environment resulting in a L(E)C50 < 1 mg/L.
Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.